Classification-Directed Treatment of Low Back Pain
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Modified Oswestry Disability Index for Low Back Pain (0-100%)
研究概览
简要总结
The primary purpose of this proposal is to conduct a prospective, randomized, controlled clinical trial to examine whether or not treatment based on a person's direction-specific, impairment-based LBP classification is more effective than Non-specific treatment in improving short- (6 weeks) and long-term (6 and 12 months) outcomes in people with chronic LBP. We hypothesize that treatment based on a person's direction-specific, impairment-based LBP classification (Classification-specific) will result in better outcomes than Non-specific treatment. Our approach to classification-directed treatment is based on the proposal that a person's LBP is the result of adopting direction-specific strategies of movement and alignment of the spine which then are used repeatedly during the person's everyday activities. The exposure of spine tissue to repeated loading in the same direction across a day is proposed to accelerate the accumulation of stress, microtrauma, and eventually LBP. We also hypothesize that until the factors contributing to the use of the direction-specific strategies of the spine are modified, the LBP problem will persist or recur. Identification of homogeneous subgroups of people with LBP will enhance 1) the power of clinical trials, 2) prognosis, and 3) the ability to identify mechanisms contributing to different LBP problems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People who report a history of chronic LBP for a minimum of 12 months,currently are experiencing LBP symptoms but not in an acute recurrence,
- •Between 18 and 60 years of age,
- •Able to stand and walk without assistance,
- •Able to understand and read English,
- •Able to understand and sign a consent form
排除标准
- •Any structural spinal deformity including scoliosis, kyphosis, or stenosis,
- •A spinal fracture or dislocation,
- •Osteoporosis,
- •Ankylosing spondylitis,
- •Rheumatoid arthritis,
- •Disc herniation,
- •Serious spinal complications such as tumor or infection,
- •Previous spinal surgery,
- •Frank neurological loss, i.e., weakness and sensory loss,
- •Pain or paresthesia below the knee,
- •Etiology of LBP other than the lumbar spine, e.g., hip joint,
- •History of neurologic disease which required hospitalization,
- •Active treatment for cancer,
- •History of unresolved cancer,
- •Pregnancy,
- •Magnified symptom behavior,
- •Worker's compensation or disability case,
- •In litigation for the LBP problem,
- •Referral from a specialized pain clinic source,
- •Spondylolisthesis
研究组 & 干预措施
2 Non-specific treatment
People in the Non-specific treatment will be provided treatment that incorporates treatment commonly cited in the literature for people with chronic LBP. The first component of treatment will consist of training in functional activities based on biomechanical principles. The second component will include general education about low back pain. The third component is exercise prescription that is directed at improving the strength and flexibility of the trunk and limbs.
干预措施: Non-specific treatment (Behavioral)
1 Classification-directed treatment
People in the Classification-directed treatment will be treated based on their direction-specific LBP classification. Treatment will consist of 3 primary components. The first component of treatment will be analysis and instruction in modification of the person's direction-specific alignment and movement strategies during symptomatic functional activities and activities in which the person uses similar strategies to those displayed with symptomatic functional activities. The second component is education about the principles of tissue injury and healing and the need to keep active. The third component is exercise prescription that consists of practice in performance of modified versions of the direction-specific impairment tests from the exam, with an emphasis on impairments that can be modified to eliminate symptoms.
干预措施: Classification-directed treatment (Behavioral)
结局指标
主要结局
Modified Oswestry Disability Index for Low Back Pain (0-100%)
时间窗: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase
Functional limitation measure
次要结局
- SF-36 Bodily Pain subscale (0-100%)(Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase)
- Kinematic measures of select movements and postures(Baseline, completion of treatment phase)
- Medication use (yes, no)(Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase)
- Fear Avoidance Beliefs Questionnaire Work subscale (0-42 points)(Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase)
- Numeric pain rating scale (0-10 points)(Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase)
- SF-36 Role Functioning-Emotional subscale (0-100%)(Baseline, completion of treatment phase, 6 months, 12 months)
- Days of low back pain-related time off (number)(Baseline, 6 months after treatment phase, 12 months after treatment phase)
- SF-36 Physical Functioning subscale (0-100%)(Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase)
- SF-36 Role Functioning-Physical subscale (0-100%)(Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase)
- SF-36 Social Functioning Subscale (0-100%)(Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase)
- Adherence to exercise (0-100%)(Second treatment visit, completion of treatment phase, 6 months after treatment phase, 12 months after treatment phase)
- Baecke Habitual Activity Measure (3-15 points)(Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase)
- SF-36 Role Functioning subscale (0-100%)(Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase)
- SF-36 General Health subscale (0-100%)(Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase)
- SF-36 Vitality subscale (0-100%)(Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase)
- Fear Avoidance Beliefs Activity subscale (0-24 points)(Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase)
- SF-36 Mental Health subscale (0-100%)(Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase)
- Adherence to training in performance of functional activities (0-100%)(Second treatment visit, completion of treatment phase, 6 months post-treatment phase, 12 months post-treatment phase)
研究者
Linda Van Dillen
Associate Professor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)